{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,13]],"date-time":"2026-05-13T02:12:49Z","timestamp":1778638369702,"version":"3.51.4"},"reference-count":13,"publisher":"Georg Thieme Verlag KG","issue":"04","license":[{"start":{"date-parts":[[2024,5,6]],"date-time":"2024-05-06T00:00:00Z","timestamp":1714953600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmacopsychiatry"],"published-print":{"date-parts":[[2024,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>\n          IntroductionCariprazine is an atypical dopamine receptor partial agonist\n                    antipsychotic available in the form of capsules. Although capsules are one of\n                    the most desirable routes of administration, there are certain situations\n                    (e.\u2009g., in an acute psychiatric setting, or when swallowing difficulties, or\n                    liquid shortages are present) when they cannot be administered. Therefore,\n                    alternative solutions like orodispersible tablets are needed. This study aimed\n                    to investigate the bioequivalence of a newly developed orodispersible tablet to\n                    the commercially available hard gelatine capsule of cariprazine 1.5\u2009mg.<\/jats:p><jats:p>\n          MethodsThis was a phase I, open-label, randomized, single-dose\n                    bioequivalence study. It had a 2-period, 2-sequence, cross-over design, where\n                    each subject received one test and one reference product in a randomized\n                    sequence, separated by a wash-out period of 55 days. Blood sampling was\n                    performed over 72\u2009h after dosing. Cariprazine concentrations were analyzed by a\n                    validated HPLC-MS\/MS method. Standard bioequivalence statistics was applied to\n                    PK parameters calculated by non-compartmental analysis. Safety measures were\n                    analyzed descriptively.<\/jats:p><jats:p>\n          ResultPharmacokinetic data of 43 healthy volunteers and safety data of 54\n                    subjects was analyzed. Cariprazine AUC0\u201372h and Cmax\n                    geometric mean ratios were 117.76% and 100.88%, respectively. The 90% confidence\n                    intervals were within the pre-defined bioequivalence acceptance limits of 80.00%\n                    \u2013 125.00%. Safety data was in line with the Summary of Product Characteristics\n                    of Cariprazine.<\/jats:p><jats:p>\n          Discussion The result of this clinical trial proved the bioequivalence of\n                    the new orodispersible tablet formulation when compared to hard gelatine\n                    capsules, enabling an alternative option for treatment of those suffering from\n                    schizophrenia.<\/jats:p>","DOI":"10.1055\/a-2291-7130","type":"journal-article","created":{"date-parts":[[2024,5,6]],"date-time":"2024-05-06T23:01:29Z","timestamp":1715036489000},"page":"180-185","source":"Crossref","is-referenced-by-count":3,"title":["Cariprazine Orodispersible Tablet: A New Formulation for\n                    Cariprazine"],"prefix":"10.1055","volume":"57","author":[{"given":"Vikt\u00f3ria","family":"Mesz\u00e1r","sequence":"additional","affiliation":[{"name":"Research Directorate, Gedeon Richter Plc, Budapest,\n                    Hungary"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gabriella","family":"Magyar","sequence":"additional","affiliation":[{"name":"Research Directorate, Gedeon Richter Plc, Budapest,\n                    Hungary"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gabriella M\u00e9sz\u00e1rosn\u00e9","family":"P\u00e1sztor","sequence":"additional","affiliation":[{"name":"Research Directorate, Gedeon Richter Plc, Budapest,\n                    Hungary"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bal\u00e1zs","family":"Szatm\u00e1ri","sequence":"additional","affiliation":[{"name":"Research Directorate, Gedeon Richter Plc, Budapest,\n                    Hungary"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Krisztina","family":"P\u00e9ter","sequence":"additional","affiliation":[{"name":"Research Directorate, Gedeon Richter Plc, Budapest,\n                    Hungary"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"L\u00edvia","family":"Marton","sequence":"additional","affiliation":[{"name":"Research Directorate, Gedeon Richter Plc, Budapest,\n                    Hungary"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zs\u00f3fia B.","family":"Dombi","sequence":"additional","affiliation":[{"name":"Research Directorate, Gedeon Richter Plc, Budapest,\n                    Hungary"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"\u00c1gota","family":"Barab\u00e1ssy","sequence":"additional","affiliation":[{"name":"Research Directorate, Gedeon Richter Plc, Budapest,\n                    Hungary"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"194","published-online":{"date-parts":[[2024,5,6]]},"reference":[{"key":"ref3","doi-asserted-by":"publisher","first-page":"1103","DOI":"10.1016\/S0140-6736(17)30060-0","article-title":"Cariprazine versus risperidone monotherapy for treatment of predominant negative\n                    symptoms in patients with schizophrenia: A randomised, double-blind, controlled\n                    trial","volume":"389","author":"G N\u00e9meth","year":"2017","journal-title":"Lancet"},{"key":"ref4","doi-asserted-by":"publisher","first-page":"154","DOI":"10.1097\/YIC.0000000000000351","article-title":"The effectiveness and safety of cariprazine in schizophrenia patients with\n                    negative symptoms and insufficient effectiveness of previous antipsychotic\n                    therapy: An observational study","volume":"36(3)","author":"E Rancans","year":"2021","journal-title":"Int Clin Psychopharmacol"},{"key":"ref5","doi-asserted-by":"publisher","first-page":"282","DOI":"10.1016\/j.schres.2018.08.020","article-title":"Efficacy of cariprazine on negative symptoms in patients with acute\n                    schizophrenia: A post hoc analysis of pooled data","volume":"204","author":"W Earley","year":"2019","journal-title":"Schizophr Res"},{"key":"ref6","doi-asserted-by":"publisher","first-page":"939","DOI":"10.1016\/S0140-6736(19)31135-3","article-title":"Comparative efficacy and tolerability of 32 oral antipsychotics for the acute\n                    treatment of adults with multi-episode schizophrenia: A systematic review and\n                    network meta-analysis","volume":"394","author":"M Huhn","year":"2019","journal-title":"Lancet"},{"key":"ref7","doi-asserted-by":"publisher","first-page":"957","DOI":"10.2147\/NDT.S301225","article-title":"Safety and tolerability of cariprazine in patients with schizophrenia: A pooled\n                    analysis of eight phase ii\/iii studies","volume":"17","author":"\u00c1 Barab\u00e1ssy","year":"2021","journal-title":"Neuropsychiatr Dis Treat"},{"key":"ref8","doi-asserted-by":"crossref","first-page":"109","DOI":"10.2147\/PPA.S27344","article-title":"Orally disintegrating olanzapine review: Effectiveness, patient preference,\n                    adherence, and other properties","volume":"6","author":"W Montgomery","year":"2012","journal-title":"Patient Prefer Adherence"},{"key":"ref9","doi-asserted-by":"publisher","first-page":"41","DOI":"10.1097\/00004850-199501005-00008","article-title":"The content and context of compliance","volume":"9","author":"P E Bebbington","year":"1995","journal-title":"Int Clin Psychopharmacol"},{"key":"ref10","doi-asserted-by":"publisher","first-page":"196","DOI":"10.1176\/ps.49.2.196","article-title":"Compliance with medication regimens for mental and physical disorders","volume":"49","author":"J A Cramer","year":"1998","journal-title":"Psychiatr Serv"},{"key":"ref11","doi-asserted-by":"publisher","first-page":"724","DOI":"10.1093\/schbul\/sbj075","article-title":"Defining and assessing adherence to oral antipsychotics: A review of the\n                    literature","volume":"32","author":"D I Velligan","year":"2006","journal-title":"Schizophr Bull"},{"key":"ref12","doi-asserted-by":"crossref","first-page":"336","DOI":"10.1192\/apt.bp.106.003194","article-title":"Why don\u2019t patients take their medicine? Reasons and solutions in psychiatry","volume":"13(5)","author":"A J Mitchell","year":"2007","journal-title":"Adv in Psychiatr Treat"},{"key":"ref13","doi-asserted-by":"publisher","first-page":"3","DOI":"10.1177\/0269881119889296","article-title":"Evidence-based guidelines for the pharmacological treatment of schizophrenia:\n                    Updated recommendations from the British Association for Psychopharmacology","volume":"34(1)","author":"TR E Barnes","year":"2020","journal-title":"J Psychopharmacol"},{"key":"ref14","doi-asserted-by":"crossref","first-page":"437","DOI":"10.1016\/j.psc.2007.04.002","article-title":"Antipsychotic medication adherence in schizophrenia","volume":"30(3)","author":"M J Byerly","year":"2007","journal-title":"Psychiatr Clin N Am"},{"key":"ref15","doi-asserted-by":"publisher","first-page":"4","DOI":"10.3390\/pharmacy11010004","article-title":"Enhancing outcomes: Acceptability of medication formulations for the treatment\n                    of acute agitation in a psychiatric population","volume":"11(1)","author":"R E Walker","year":"2022","journal-title":"Pharm"}],"container-title":["Pharmacopsychiatry"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/www.thieme-connect.de\/products\/ejournals\/pdf\/10.1055\/a-2291-7130.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,11,5]],"date-time":"2024-11-05T17:16:49Z","timestamp":1730827009000},"score":1,"resource":{"primary":{"URL":"http:\/\/www.thieme-connect.de\/DOI\/DOI?10.1055\/a-2291-7130"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,5,6]]},"references-count":13,"journal-issue":{"issue":"04","published-online":{"date-parts":[[2024,7,9]]},"published-print":{"date-parts":[[2024,7]]}},"URL":"https:\/\/doi.org\/10.1055\/a-2291-7130","archive":["Portico","CLOCKSS"],"relation":{},"ISSN":["0176-3679","1439-0795"],"issn-type":[{"value":"0176-3679","type":"print"},{"value":"1439-0795","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,5,6]]}}}